Neupro

Orange BookUNIISPLATC N04BC09

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerUCB, Inc.

CountryUS (United States)

ATC codeN04BC09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5047480103
30 POUCH in 1 CARTON (50474-801-03) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH
ndc11
5047480117
7 POUCH in 1 CARTON (50474-801-17) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH

Annotations

UNII (FDA Substance ID)

87T4T8BO2E

ROTIGOTINE

RxCUI 616739

Orange Book

N021829

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "87T4T8BO2E",
    "rxcui": "616739",
    "inchikey": "KFQYTPMOWPVWEJ-INIZCTEOSA-N",
    "display_name": "ROTIGOTINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TRANSDERMAL",
  "spl_meta": {
    "939e28c5-f3a9-42c0-9a2d-8d471d82a6e0": {
      "match": "brand_token",
      "title": "NEUPRO (ROTIGOTINE) PATCH, EXTENDED RELEASE NEUPRO (ROTIGOTINE) KIT [UCB, INC.]",
      "spl_version": "20",
      "published_date": "2025-06-26"
    }
  },
  "productid": "50474-801_385797e6-a44d-f4af-e063-6294a90a178a",
  "productndc": "50474-801",
  "dosage_form": "PATCH, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "021829",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2MG/24HR",
        "product_no": "001",
        "approval_date": "May 9, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "4MG/24HR",
        "product_no": "002",
        "approval_date": "May 9, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "6MG/24HR",
        "product_no": "003",
        "approval_date": "May 9, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "1MG/24HR",
        "product_no": "004",
        "approval_date": "Apr 2, 2012"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "3MG/24HR",
        "product_no": "005",
        "approval_date": "Apr 2, 2012"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "8MG/24HR",
        "product_no": "006",
        "approval_date": "Apr 2, 2012"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ROTIGOTINE",
  "proprietary_name": "Neupro",
  "active_ingred_unit": "mg/24h",
  "application_number": "NDA021829",
  "marketing_category": "NDA",
  "nonproprietary_name": "rotigotine",
  "start_marketing_date": "20120402",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code N04BC09.

Access this data programmatically

Query Neupro and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs